Efficacy Study of Acupuncture to Treat Spinal Pain

This study is currently recruiting participants.
Verified February 2014 by Daegu Catholic University Medical Center
Sponsor:
Information provided by (Responsible Party):
Un-Suk, Noh (PhD), Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier:
NCT01909284
First received: July 18, 2013
Last updated: February 2, 2014
Last verified: February 2014
  Purpose

This study is being conducted to investigate the effectiveness and safety of acupuncture for alleviating pain of spondylosis.


Condition Intervention
Low Back Pain
Device: Acupuncture
Procedure: Epidural nerve block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Efficacy and Safety of Acupuncture on Patient With Spinal Pain Due to Spondylolithesis

Resource links provided by NLM:


Further study details as provided by Daegu Catholic University Medical Center:

Primary Outcome Measures:
  • Visual analogue scale(VAS) [ Time Frame: Change from baseline to 5 weeks ] [ Designated as safety issue: No ]
    This outcome will measure changes in the participant's level of low back pain.


Secondary Outcome Measures:
  • Short form McGill pain questionnaire [ Time Frame: Chagnes from baseline to 5 weeks ] [ Designated as safety issue: No ]
  • Oswestry Disability Index [ Time Frame: Changes from baseline to 5 weeks ] [ Designated as safety issue: No ]
  • Present pain intensity(PPI) [ Time Frame: Changes from baseline to 5 weeks ] [ Designated as safety issue: No ]
  • Pain vision [ Time Frame: Chagnes from baseline to 5 weeks ] [ Designated as safety issue: No ]
    A device Pain vision Ⓡ PS-2100 calculates a "degree of pain" in cancer patients in addition to VAS


Other Outcome Measures:
  • Safety [ Time Frame: After the initiation of acupuncture, 2 weeks, and 4 weeks ] [ Designated as safety issue: Yes ]
    We will confirm the safety of acupuncture by determining the red blood cell (RBC) count, hemoglobin level, platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), hematocrit (Hct), total white blood cell (WBC) count, Erythrocyte Sedimentation Rate (ESR), aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum urea nitrogen (BUN), creatinine level, serum sodium level, serum potassium level, and serum chloride level. All patients were evaluated 3 times, including a final follow-up visit 4 weeks after the initiation of acupuncture.


Estimated Enrollment: 14
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture & Epidural nerve block
acupuncture plus epidural block
Device: Acupuncture
  • BL40, BL60, ST36, GB34 : bilaterally, manual acupuncture.
  • Two points on 1st bladder meridian nearest location of back pain : bilaterally, electrical acupuncture.
Procedure: Epidural nerve block
Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).
Active Comparator: Epidural nerve block
epidural block alone
Procedure: Epidural nerve block
Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).

Detailed Description:

This study is being conducted at the Daegu Catholic University Medical Center. Enrolled participants will be randomized into two groups : acupuncture treatment plus epidural block and epidural block alone.

This trial will include treatments during 3 weeks, and then follow up after 2 weeks. Participants will have acupuncture treatments of three times per week and epidural block of once per week. All examinations and treatments will be provided free of charge. Compared with epidural block group, acupuncture plus epidural block group will give more effectiveness for alleviate pain caused by lumbar spondylosis.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 65 years
  • Meyerding Grade I-II spondylolisthesis
  • Low back pain of at least 1-year duration
  • Follow-up possible during the clinical trial
  • Written informed consent voluntarily

Exclusion Criteria:

  • Cauda equina syndrome, persistently exacerbated symptoms, progressive neurologic signs (sensory or motor changes)
  • Previous spine surgery
  • Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders
  • Severe, concomitant disease (neuromuscular scoliosis, neurodegenerative disease)
  • All contraindications to corticosteroid injection (e.g., insulin-dependent diabetes)
  • Alcohol/drug abuse
  • Significant renal or hepatic disease
  • Pregnant, lactating or planning a pregnancy
  • Hypersensitive reaction to acupuncture treatment
  • Inability to comprehend or express oneself in the Korean language
  • An individual deemed to be ineligible by a physician
  • Refusal to participate in the trial or to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01909284

Contacts
Contact: Un-Suk Noh, M.D,Ph.D +82 53 650 4054 usno@cu.ac.kr

Locations
Korea, Republic of
Daegu Catholic University Medical Center Recruiting
Daegu, Kyungsangbukdo, Korea, Republic of
Sponsors and Collaborators
Daegu Catholic University Medical Center
Investigators
Principal Investigator: Jeong-chul Seo, KMD, Ph.D. Comprehensive and Intergrative Medicine Institute
Principal Investigator: Min-Ah Gwak, KMD, Ph.D. Daegu Oriental Hospital of Daegu Haany University
Principal Investigator: Seong-Hoon Park, KMD Comprehensive and Integrative Medicine Insitute
  More Information

No publications provided

Responsible Party: Un-Suk, Noh (PhD), Department of anesthesiolgy, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT01909284     History of Changes
Other Study ID Numbers: CIMI-13-01-20
Study First Received: July 18, 2013
Last Updated: February 2, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014